PIKfyve blockade exposes lysosomal vulnerability in myeloma

Recognizing these barriers, in 2024 the FDA issued 3 draft guidance documents related to clinical trial eligibility, addressing laboratory values, performance status, and washout periods/concomitant medications. 2,4Recommendations emphasized tailoring eligibility criteria to the investigational drug's mechanism of action, including patients with an Eastern Cooperative Oncology Group performance status 2, and liberalizing laboratory thresholds when supported by safety data.